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PATHFINDER 2 Study Results Presented at ESMO 2025 October 20, 2025 1
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This presentation contains forward-looking statements. In some cases, you can identify these statements by forward-looking words such as “aim,” “anticipate,” “believe,”“continue,”“could,”“estimate,”“expect,” “intend,”“may,” “might,” “plan,” “potential,”“predict,”“should,” “would,” or “will,” the negative of these terms, and other comparable terminology. These forward-looking statements, which are subject to risks, uncertainties, and assumptions about us, may include expectations and projections of our future financial performance, future tests or products, technology, clinical studies and data, regulatory compliance, potential market opportunity, anticipated growth strategies, future sales, restructuring costs, submission of our test results for presentation, sufficiency of cash on hand to finance our business, cost savings, budgets and strategies, restructuring and stock-based compensation costs, impact of the restructuring on our operations and growth, FDA approval of our products, commercial reimbursement of our products, and anticipated trends in our business. These statements are only predictions based on our current expectations and projections about future events and trends. There are important factors that could cause our actual results, level of activity, performance, or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements, including those factors and numerous associated risks discussed under the section entitled“RiskFactors” in our Annual Report of Form 10-K filed for the year ended December 31, 2024, as updated by our Quarterly Reports on Form 10-Q and our other reports filed with the SEC. Moreover, we operate in a dynamic and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results, level of activity, performance, or achievements to differ materially and adversely from those contained in any forward-looking statements we may make. Forward-looking statements relate to the future and, accordingly, are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of our control. Although we believe the expectations and projections expressed or implied by the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance, or achievements. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Except to the extent required by law, we undertake no obligation to update any of these forward-looking statements after the date of this presentation to conform our prior statements to actual results or revised expectations or to reflect new information or the occurrence of unanticipated events. This presentation also contains preliminary select financial results which are unaudited and subject to change. We will report our final and complete financial results in February 2026. 2
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3 The largest two MCED studies to-date form Galleri’s registrational program NHS-Galleri Longitudinal clinical utility in screening-eligible intended-use • Prospective, interventional randomized controlled trial of Galleri added to standard of care (UK) • Repeat testing to demonstrate value of annual screening, plus 12 months follow up • 140,000 participants PATHFINDER 2 Performance & safety in screening-eligible intended-use • Prospective, interventional study of Galleri added to standard of care (US) • Single time point testing (one blood draw), plus 12 months follow up • 35,000 participants Prespecified analysis of first 25,000 enrolled was presented this weekend at ESMO Congress 2025 Full longitudinal clinical utility results expected mid-2026 MCED: multi-cancer early detection. NHS: National Health Service (UK). ESMO: European Society for Medical Oncology.
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4 Strengthened balance sheet with two transactions Samsung C&T and Samsung Electronics. 1 Cash, cash equivalents, and short-term marketable securities. Stated runway based on cash balance does not include the agreemen t by Samsung C&T and Samsung Electronics to invest $110M in GRAIL, which is subject to closing conditions.. Strategic partnership with Samsung (announced Oct. 16) • Exclusive partners to commercialize the Galleri test in South Korea, with a possible extension into other Asian geographies • To explore additional potential strategic and operational collaborations • Includes $110M equity investment by Samsung in GRAIL, subject to closing conditions $325M private placement financing (announced today) • Participation by new and existing institutional investors, including Deep Track Capital, Farallon Capital Management, Hims & Hers, Braidwell LP, three life sciences investment firms, and a tech and life sciences focused family office investment firm • Resulting cash balance provides runway into 20301
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5 PATHFINDER 2: Performance and safety study in screening-eligible intended-use CSO, cancer signal origin. PET-CT, positron-emission tomography-computerized tomography. 1 All participants will be actively followed by enrolled institution for three years to assess cancer status and collect participant-reported outcomes. 2 Clinical information including but not limited to cancer type, pathologic, imaging and clinical staging information will be c aptured. ~35,000 participants Blood drawn / processed and MCED test report generated Cancer signal detected No cancer signal detected Patient informed of MCED test result; outcomes followed 1 Patient informed of MCED test result; diagnostic follow-up procedures 1 (per protocol based on CSO) Confirmatory PET -CT2 / research blood draw Cancer identified No cancer identified Diagnostic resolution and data capture 2 STUDY OBJECTIVES • Evaluate performance and safety of Galleri MCED test in eligible individuals for cancer screening • Assess number and types of diagnostic procedures needed for resolution
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Cancer Status Over 12 Months of Follow-up (Performance Analyzable Cohort) Cancer Diagnosis (n=329) No Cancer Diagnosis (n=22,832) Total (N=23,161) Performance Metric (95% CI) MCED Test Result Positive 133 83 216 PPV 61.6% (54.9-67.8%) Negative 196 22,749 22,945 NPV 99.1% (99.0-99.3%) Performance Metric (95% CI) Episode Sensitivitya 40.4% (35.3-45.8%) Specificity 99.6% (99.5-99.7%) Observed PPV Was ~62% Across All Cancers CI, confidence interval; MCED, multi-cancer early detection; NPV, negative predictive value; PPV, positive predictive value. aThe proportion of cancers diagnosed within 12 months of MCED testing that were correctly identified by the test at the time it w as performed. 1. Schrag D, et al. Lancet. 2023;402(10409):1251-1260. 2. Klein EA, et al. Ann Oncol. 2021;32(9):1167-1177. 3. Matrana M, et al. Poster presented at American Association for Cancer Research (AACR) Annual Meeting; April 25-30, 2025; Chicago, Illinois. 4. Atwood C, et al. Presented at Early Detection of Cancer Conference (EDCC); October 22-24, 2024; San Francisco, California. 5. Lehman CD, et al. Radiology. 2017;283:49–58. 6. Bailey SER, et al. Br J Cancer 2021;124:1231–1236. 7. Pinsky PF, et al. Ann. Intern. Med. 2015;162:485–491. 8. Sekiguchi M, et al. Sci Rep. 2020;10, 18202. 9. Pickhardt PJ, et al. AJR Am J Roentgenol. 2021;217:817–830. ●MCED test PPV ranged from 42.9%-49.4% in prior clinical studies and real-world experience1-4 ●The MCED test PPV is an order of magnitude higher than established single-cancer screening tests5-9
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Demonstrated Robust 12-Month Episode Sensitivity in Clinically Relevant Subgroups CI, confidence interval. aAnus, Bladder/urothelial tract, Colon/rectum, Esophagus, Head and neck, Liver/intrahepatic bile duct, Lung, Lymphoid lineage,Ovary/fallopian tube, Pancreas/extrahepatic bile duct/gallbladder, Plasma cell lineage, Stomach. bEsophagus, Liver/intrahepatic bile duct, Lung, Ovary/fallopian tube, Pancreas/extrahepatic bile duct/gallbladder, Stomach. cAnus, Bladder/urothelial tract, Bone/soft tissue sarcoma, Esophagus, Head and neck, Kidney, Liver/intrahepatic bile duct, Lung, Lymphoid lineage, Myeloid lineage, Ovary/fallopian tube, Pancreas/extrahepatic bile duct/gallbladder, Plasma cell lineage, Skin, Stomach, Thyroid, Uterus, Other. 50% 12 cancers responsible for ⅔ US cancer deathsa 6 aggressive cancers with low 5 -year survivalb All cancers except breast and prostate cancers Cancers without common screening optionsc 73.7% (65.6-80.4%) 71.7% (59.2-81.5%) 56.4% (49.4-63.2%) 54.9% (47.7-62.0%) Episode Sensitivity (95% CI)
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MCED Testing Increased the Number of Screen-Detected Cancers Over 7x When Added to Recommended Screeninga MCED, multi-cancer early detection; USPSTF, United States Preventive Services Task Force. aUSPSTF grade A/B recommendations include screening for breast, cervical, colorectal, and lung cancers. bClinically-detected cancers included those detected incidentally (n=62), by signs and symptoms (n=40), by surveillance (n=21), and other (n=6; 3 were follow-up after an abnormal test result, 2 were incidental findings, and 1 was unknown). cMCED-detected refers to cancers diagnosed within 12 months following a positive MCED test result. dUSPSTF grade A/B/C recommendations include screening for breast, cervical, colorectal, lung, and prostate cancers. 200 (61%) Screen-detected cancers 129 (39%) Clinically-detected cancersb MCED cancer detection rate was 0.57%, translating to a number needed to screen of 174 to detect 1 cancer. Screen-detected breast, cervical, colorectal, or lung cancers a Screen-detected breast, cervical, colorectal, lung, or prostate cancers d ~3x >7x 329 participants diagnosed with cancer during 12 months of follow -up 133 MCED-detectedc20 47 20 20 20 47 133 MCED-detectedc 67
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Majority of MCED-Detected Cancersa Do Not Have Common Screening Options MCED, multi-cancer early detection. aMCED-detected refers to cancers diagnosed within 12 months following a positive MCED test result. bUSPSTF grade A/B recommendations include screening for breast, cervical, colorectal, and lung cancers. Solid Cancers N=107 Hematological Cancers N=26 ●133 participants with cancers diagnosed across a broad range of cancer types ○114 new primary cancers, 18 recurrent cancers, 1 unknown primary site ●73% of all MCED- detected cancersa do not have recommended screening optionsb For participants with multiple primary cancers, only information from the first diagnosed cancer is included in the participant-level summary. Cancers with screening (breast, cervical, colorectal, lung) Cancers without screening
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Most MCED-Detected New Cancersa,b Were Detected at Early Stages MCED, multi-cancer early detection; TNM, tumor node metastasis. aMCED-detected refers to cancers diagnosed within 12 months following a positive MCED test result. bFor participants with multiple primary cancers, only information from the first diagnosed cancer is included in the participant- level summary. cNo TNM stage is expected for cancers such as brain and spinal cord, leukemia, myeloma and plasma cell disorders, polycythemia ve ra, and cancer of unknown primary. dUSPSTF grade A/B recommendations include screening for breast, cervical, colorectal, and lung cancers. 33.3%Stage I (n=38) 20.2% 15.8% 24.8% No TNM stage expectedc (n=6) 5.3% Missing(n=1) 0.9% Stage II (n=23) Stage III (n=18) Stage IV (n=28) Stage I-II: 53.5% Stage I-III: 69.3% 74% of stage I-II cancers do not have recommended screening options d ● Head & Neck (n=14) ● Liver (n=10) ● Colon/Rectum (n=8) ● Lymphoid lineage (n=7) ● Breast (n=5) ● Pancreas (n=4) ● Anus (n=3) ● Kidney (n=3) ● Lung (n=3) ● Plasma cell lineage (n=2) ● Bladder, Urothelial tract (n=1) ● Other - Testis (n=1)
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Accurate CSO Predictions Guided Rapid Diagnosis Following a Positive MCED Test Result CI, confidence interval; CSO, cancer signal origin; IQR, interquartile range; MCED, multi-cancer early detection. aBased on Kaplan-Meier analysis. 36 (24-61) daysTrue Positive False Positive 75 (42-136) days 46 (42-59) days All MCED Positive Participantsa Median (IQR) Days to Diagnostic Resolution (95% CI: 85.8-95.3%) first CSO prediction accuracy in true positives 91.7%
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The MCED Test Was Safe When Implemented in the Intended Use Population MCED, multi-cancer early detection. Of 25,114 safety analyzable participants who received the MCED test (data cutoff December 31, 2024): At the time of the initial analysis, no serious, study -related adverse events reported during the diagnostic worku p 0.6% had an invasive procedure to evaluate a positive MCED result
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MCED, multi-cancer early detection; PPV, positive predictive value. aUSPSTF grade A/B recommendations include screening for breast, cervical, colorectal, and lung cancers. 1 . Schrag D, et al. Lancet. 2023;402(10409):1251-1260. 2 . Klein EA, et al. Ann Oncol. 2021;32(9):1167-1177. Initial PATHFINDER 2 Results Demonstrated Robust Performance and Safety Across a Broad Popula tion Increased the number of cancers detected by >7x when added to recommended screeninga Demonstrated robust performance, with a ~62% PPV — substantially higher than that observed in prior clinical studies 1-2 Enabled prompt, efficient diagnostic resolution with a favorable safety profile In the largest interventional MCED study conducted in the US to date, the MCED test:
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14 Q&A Advancing towards our vision of population-scale multi-cancer early detection